| CTRI Number |
CTRI/2025/01/079643 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study which drug is better whether Krishna Awaleha or Shati Compound syrup in the management of Vataja Kasa (Allergic cough, Acute cough) in children of age group 3 to 10 years. |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Krishna Awaleha in the management of Vataja Kasa in children of age group 3 to 10 years. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejal Avinash Sharma |
| Designation |
PG scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre Nigdi pune |
| Address |
PDEAS College of Ayurved and Research Centre Balrog Department third floor Nigdi Pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
8446551759 |
| Fax |
|
| Email |
sharma.tejal912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejal Avinash Sharma |
| Designation |
PG scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre Nigdi pune |
| Address |
PDEAS College of Ayurved and Research Centre Balrog Department third floor Nigdi Pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
8446551759 |
| Fax |
|
| Email |
sharma.tejal912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
Professor and HOD |
| Affiliation |
PDEAS College of Ayurved and Research Centre Nigdi Pune. |
| Address |
PDEAS College of Ayurved and Research Centre Balrog Department third floor Nigdi Pune Maharashtra India
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Research Centre
sector 25
Pradhikaran Nigdi Pune.
State- Maharashtra
country-India.
Pincode- 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAS College of Ayurved and Research Centre
sector 25, Pradhikaran Nigdi Pune
State- Maharashtra
Country-India.
PINCODE- 411044 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tejal Avinash Sharma |
Ayurveda Rugnalaya and Sterling Multispeciality Hospital Nigdi Pradhikaran Pune |
Vitthal Rukmini road Sector 27
Kaumarbhritya OPD no 118 Nigdi Pradhikaran
Pune Maharashtra
Pune
MAHARASHTRA |
8446551759
sharma.tejal912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J06||Acute upper respiratory infections. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krishna Awaleha, Reference: Yogaratnakara , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 230(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: the dose in children is given according to the body weight hence the given dose is 230 mg per kg per dose | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shati compound syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 0.8(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: -the dose in children is given according to the body weight hence the given dose is 0.8 ml per kg per dose |
|
|
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having any 2 or more classical signs and symptoms of Vataja Kasa described in classical texts such as Shushka Kasa, Shirashoola, Swarabheda, Parshwashoola, Shushka mukha and gala, Uroshoola.
Children in the age group of 3 to 10 years will be selected irrespective of religion and gender.
Subjects having Kasa with acute onset that is symptoms for less than 7 days duration.
Patients with the history of allergic cough |
|
| ExclusionCriteria |
| Details |
1. Kasa as Anubandha Lakshan in other systemic diseases.
2. patients presenting with symptoms of Tamaka Shwasa. Kasa associated with Jwara.
3. K/C/O Pneumonia, Emphysema, Diphtheria, Pertusis, Bronchiectasis, Lung abscess, Pulmonary edema, Obstructive bronchitis.
4. k/c/o Kochs, HIV, Congenital anomalies.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Krishna Awaleha in the management of Vataja Kasa on the basis of the symptoms like Shushka Kasa , Swarabheda, Mukha gala shushkata, Parshwashoola, Shirashoola, Uroshoola. |
7days. Wehere follow up will be on 3rd, 5th and 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the side effects if any. |
7 days. where follow up will be on 3rd, 5th and 7th day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Respiratory track infections are very common in pediatric age group with cough being the most common and frequent symptom.In Ayurveda cough or Kasa is not just a symptom but a disease and chronicity of Kasa leads to Kshaya which has multi system involvement. It is important to treat any diseases in pediatric age group at the earliest as it may hamper the growth and developement of the child.
Kasa is the disease of Pranavaha Srotasa. and as Prana is affected in Kasa, so it has to be treated with priority.
Vataja Kasa can be co-related with allergic cough with its clinical manifestation.
In recent years the incidents of Kasa specifically Vataja Kasa or allergic cough has increased due to exposure to both active and passive smoke and air pollution. After Covid 19 pandemic we are facing the problem of low immunity and incresed cases of respiratory track infections.
Properties of Krishna Awaleha are Deepaniya, Karshyahara, Pachaniya, Kasahara. Krishna Awaleha have been specifically mentioned to be effective in children. Hence, this drug has been selected for the study.
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